FENTANYL (Page 2 of 17)

2.3 Initial Dosage

Do not initiate treatment with fentanyl transdermal system in opioid nontolerant patients [see Contraindications (4)].

The recommended starting dose when converting from other opioids to fentanyl transdermal system is intended to minimize the potential for overdosing patients with the first dose.

Conversion From Other Opioids to Fentanyl Transdermal System

When fentanyl transdermal system therapy is initiated, discontinue all other opioid analgesics other than those used on an as needed basis for breakthrough pain when appropriate.

While there are useful tables of opioid equivalents readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products. As such, it is preferable to underestimate a patient’s 24-hour fentanyl requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour fentanyl requirements which could result in adverse reactions. In a fentanyl transdermal system clinical trial, patients were converted from their prior opioid to fentanyl transdermal system using Table 1 as a guide for the initial fentanyl transdermal system dose.

Each fentanyl transdermal system is worn continuously for up to 72 hours [see Dosage and Administration (2.7)].

When converting patients from oral or parenteral opioids to fentanyl transdermal system, use Table 1 (alternatively use Table 2 for adult and pediatric patients taking opioids or doses not listed in Table 1) and consider the following:

These are not tables of equianalgesic doses.
The conversion doses in these tables are only for the conversion from one of the listed oral or parenteral opioid analgesics to fentanyl transdermal system.
The tables cannot be used to convert from fentanyl transdermal system to another opioid because these conversions will result in an overestimation of the dose of the new opioid (these conversions are conservative) and may result in fatal overdosage.
Table 1*: Dose Conversion from Other Opioids to Fentanyl Transdermal System
*
Table 1 should not be used to convert from fentanyl transdermal system to other therapies because this conversion to fentanyl transdermal system is conservative. Use of Table 1 for conversion to other analgesic therapies can overestimate the dose of the new agent. Overdosage of the new analgesic agent is possible [see Dosage and Administration (2.9)].

Current Analgesic

Daily Dosage (mg/day)

Oral morphine

60‒134

135‒224

225‒314

315‒404

Intramuscular or Intravenous morphine

10‒22

23‒37

38‒52

53‒67

Oral oxycodone

30‒67

67.5‒112

112.5‒157

157.5‒202

Oral codeine

150‒447

Oral hydromorphone

8‒17

17.1‒28

28.1‒39

39.1‒51

Intravenous hydromorphone

1.5‒3.4

3.5‒5.6

5.7‒7.9

8‒10

Intramuscular meperidine

75‒165

166‒278

279‒390

391‒503

Oral methadone

20‒44

45‒74

75‒104

105‒134

Recommended Fentanyl Transdermal System Dose

25 mcg/hour

50 mcg/hour

75 mcg/hour

100 mcg/hour

Alternatively, for adult and pediatric patients taking opioids or doses not listed in Table 1, use the following methodology when converting patients from oral or parenteral opioids to fentanyl transdermal system:

1.
Calculate the previous 24-hour analgesic requirement.
2.
Convert this amount to the equianalgesic oral morphine dose using a reliable reference.
3.
Refer to Table 2 for the range of 24-hour oral morphine doses that are recommended for conversion to each fentanyl transdermal system dose. Use this table to find the calculated 24‑hour morphine dose and the corresponding recommended initial fentanyl transdermal system dose.
4.
Initiate fentanyl transdermal system treatment using the recommended dose and titrate patients upwards (no more frequently than 3 days after the initial dose and every 6 days thereafter) until analgesic efficacy is attained. A 37.5 mcg/hour dose may also be used. For patients that require more than 100 mcg/hour, several transdermal systems may be used.
5.
Do not use Table 2 to convert from fentanyl transdermal system to other therapies because this conversion to fentanyl transdermal system is conservative and will overestimate the dose of the new agent.
Table 2*: Recommended Initial Fentanyl Transdermal System Dose based upon Daily Oral Morphine Dose
NOTE: In clinical trials, these ranges of daily oral morphine doses were used as a basis for conversion to fentanyl transdermal system.
*
Table 2 should not be used to convert from fentanyl transdermal system to other therapies because this conversion to fentanyl transdermal system is conservative. Use of Table 2 for conversion to other analgesic therapies can overestimate the dose of the new agent. Overdosage of the new analgesic agent is possible [see Dosage and Administration (2.9)].

Oral 24-hour

Morphine

(mg/day)

Fentanyl Transdermal System

Dose

(mcg/hour)

60‒134

25

135‒224

50

225‒314

75

315‒404

100

405‒494

125

495‒584

150

585‒674

175

675‒764

200

765‒854

225

855‒944

250

945‒1034

275

1035‒1124

300

Additional intermediate strengths 37.5 mcg/hr, 62.5 mcg/hr, and 87.5 mcg/hr fentanyl transdermal systems are available and may be considered during conversion from prior opioids or dose titration. For example, the 37.5 mcg/hr system could be used before converting or titrating to a 50 mcg/hr system. Similarly, a 62.5 mcg/hr system is available for use as an intermediate strength between the 50 mcg/hr and the 75 mcg/hr system, and an 87.5 mcg/hr system is available as an intermediate strength between the 75 mcg/hr system and the 100 mcg/hr system.

The additional intermediate strengths, 37.5 mcg/hr, 62.5 mcg/hr and 87.5 mcg/hr, were not used in the clinical studies.

For delivery rates in excess of 100 mcg/hour, multiple systems may be used.

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